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Gentium S.p.A. Receives Marketing Authorization From the European Commission (EC) for Defitelio® (Defibrotide)



10/22/2013 9:40:54 AM

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VILLA GUARDIA, Italy, Oct. 22, 2013 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") announced today that the European Commission has granted a Marketing Authorization for Defitelio® (defibrotide) for the treatment of severe hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. Defitelio® is the first approved treatment in the European Union for this life-threatening condition. This authorization is the formal endorsement of the positive opinion received from the European Medicine Agency's ("EMA") Committee for Human Medicinal Product ("CHMP") on July 26, 2013. The Company intends to begin commercialization of Defitelio® in the European Union in December 2013.

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